BACKGROUND & AIMS:
Pelvic floor muscle training (PFMT) in combination with conservative treatment is recommended as first-line treatment for patients with fecal incontinence, although its efficacy is unclear. We investigated whether supervised PFMT in combination wsith conservative treatment is superior to attention-control massage treatment and conservative treatment in adults with fecal incontinence.

METHODS:
We performed a randomized, controlled, superiority trial of patients with fecal incontinence at a tertiary care center at a public hospital in Denmark. Ninety-eight adults with fecal incontinence were randomly assigned to groups that received supervised PFMT and biofeedback plus conservative treatment or attention-control treatment plus conservative treatment. The primary outcome was rating of symptom changes, after 16 weeks, based on scores from the Patient global impression of improvement scale (PGI-I). Secondary outcomes were changes in Vaizey incontinence score (Vaizey Score), Fecal Incontinence Severity Index, and Fecal Incontinence Quality of Life Scale.

RESULTS:
In the intention to treat analysis, participants in the PFMT group were significantly more likely to report improvement in incontinence symptoms, based on PGI-I scores (unadjusted odds ratio, 5.16; 95% CI, 2.18-12.19; P = .0002). The PFMT group had a larger reduction in mean Vaizey score (reduction of -1.83 points; 95% CI, -3.57 to -0.08, P = .04). There were no significant differences in condition-specific quality of life. In the per-protocol analyses, the superiority of PFMT was increased. No adverse events were reported.

CONCLUSIONS:
In a randomized controlled trial of patients with fecal incontinence, we found that participants who received supervised PFMT group had 5-fold higher odds of reporting improvements in fecal incontinence symptoms and had a larger mean reduction of incontinence severity, based on Vaizey score. Clinicaltrials.gov no: NCT01705535.